Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea

NCT01407848 | Completed Phase 2 DMC

• 2 other identifiers: Uni-Koeln-14882011-003473-29
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.

Conditions

Transient Tachypnoea of the Newborn

Outcome Measures

Primary Outcomes (1)

• Reduction of the Silverman-Score

  The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant. Silverman Score is the standard score to describe the degree of respiratory distress of neonate.

  0-72 h or up to end of CPAP after start of the study

Secondary Outcomes (6)

• Oxygen supplementation

  0-72 h or up to end of CPAP after start of the study

• A need for secondary intubation and mechanical ventilation

  1-3 day of life

• body weight

  1-3 day of life

• CPAP-time

  0-72 h or up to end of CPAP after start of the study

• blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)

  0-72 h after start of the study

Study Arms (2)

Furosemide

EXPERIMENTAL

1 mg/kg/Ed

Drug: Furosemide

Saline 0,9%

ACTIVE COMPARATOR

1ml/kg/Ed

Drug: Saline 0,9%

Interventions

Furosemide DRUG

Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.

Also known as: inhaled furosemide

Furosemide

Saline 0,9% DRUG

nebulised 0,9% saline 4x/d for max.3 days

Also known as: natrium chloride

Saline 0,9%

Eligibility Criteria

• Age: 6 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
• The need for CPAP \>6 h to obtain the oxygen saturation \>92%
• Written informed consent of parent/guardian

You may not qualify if:

• Systemic infection
• Malformation and any other several disease with disturb of respiratory
• Subjects participating in other clinical trials

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Children´s Hospital University of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Bernhard Roth, Prof. Dr.

  University Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 2, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)